FEV1/FEV6 and FEV6 as an Alternative for FEV1/FVC and FVC in Bolivian Subjects

NCT ID: NCT03534557

Last Updated: 2018-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-02

Study Completion Date

2018-09-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Comparison of FEV1/FEV6 and FEV6 as an alternative for FEV1/FVC and FCV in the detection of airway obstruction in a Bolivian population

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The data of consecutive adult smoker patients, referred to the Clínica del Pulmón (Santa Cruz, Bolivia), between May 2018 and June 2018, will be analyzed. All the patients are current or ex-smokers, complaining of dyspnea, cough or expectorations. Spirometry measurements will be performed with a Medisoft Body Box 5500 by one highly trained and experienced pulmonologist according to the guidelines of the ATS/ERS.

The criteria used to detect airway obstruction are either the fixed cut-off points according to GOLD recommendations (FEV1/FVC\<0.70) or the lower limit of normal (FEV1/FVC\<LLN). These indices will be compared to a fixed cut-off FEV1/FEV6 \<0.73 as proposed by Vandevoorde et al. or to a FEV1/FV6 ration \< LLN. Reference equations used are those of Caucasians from the NHANES III survey.

Statistical tests will be done using IBM SPSS 24 software. Cohen's κ will be used to determine if there is an agreement between the definitions of airway obstruction.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Copd

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

COPD

FEV1/FVC and FEV1/FEV6 will be compared within the same cohort of COPD patients

FEV6 spirometry

Intervention Type DIAGNOSTIC_TEST

During the same spirometry, to compare the relative value of FVC and FEV6

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FEV6 spirometry

During the same spirometry, to compare the relative value of FVC and FEV6

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* adult smoker suspected of COPD

Exclusion Criteria

* unable to perform spirometry
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Giuseppe Liistro

Head of clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Giuseppe Liistro, MD,PhD

Role: STUDY_DIRECTOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clínica del Pulmón

Santa Cruz, , Bolivia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Bolivia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

StLucFEV6

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Auto-evaluation of Dyspnea
NCT03598569 COMPLETED